Clinical Study of MK-4884 for Advanced Solid Tumors

Researchers are studying a new treatment called MK-4884 for people with advanced or metastatic (spread to other parts of the body) solid tumors. This study aims to find out how safe different doses of MK-4884 are and if people can tolerate them. You might be able to join if you are 18 or older and have certain types of solid tumors, including colorectal, kidney (renal cell carcinoma), non-small cell lung cancer, or biliary tract cancer. The main goals are to track any serious side effects (dose-limiting toxicities) within about 21 days, and any other side effects or reasons for stopping treatment for up to 39 months.

Study design
This is an interventional study with a planned enrollment of 120 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) and reasons for discontinuing treatment for up to approximately 39 months.

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NCT07600749

Clinical Study of MK-4884 in Participants With Advanced or Metastatic Solid Tumors (MK-4884-001)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~120 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:MK-4884

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Measured over Up to approximately 21 days
+2 more outcomes measured
Malignant Neoplasm
6 sites across 5 states
Israel2
Texas1
Tokyo1
Canton of St. Gallen1
Canton Ticino1
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Eligibility criteria

Inclusion

Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
Colorectal carcinoma (CRC)
Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
Nonsquamous non-small cell lung cancer (NSCLC)
Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
Has adequate organ function
Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion

Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
Has a serious nonhealing wound, ulcer, or bone fracture
Has an active infection(s) requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery
  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)Up to approximately 21 days

    DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 39 months

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with experience an AE will be reported.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 39 months

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE will be reported.